Remote Director, Clinical Data Management: Data Strategy

Entrada Therapeutics

Boston (MA)

On-site

USD 219,000 - 245,000

Full time

14 days+

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Job summary

Entrada Therapeutics is seeking a strategic and hands-on Director of Clinical Data Management to lead data management across multiple programs, set data standards, and partner with CROs to meet timelines in compliance with FDA/ICH GCP and CDISC standards. This US-based remote role reports to the Head of Biometrics and will drive DM strategy and system implementations.

This role requires 10+ years in clinical data management, strong leadership, CRO/vendor management, and deep Medidata RAVE

Qualifications

BS in computer science, or a science-based subject, with 10+ years of clinical data management experience
Strong critical thinking and sound judgment with proven problem-solving ability
CRO vendor management, oversight, and budget management experience
Proficient in Medidata RAVE and other EDC platforms; programming experience is a plus
Experience with CDASH and SDTM terminology in trial design
Knowledge of FDA/ICH GCP guidelines and regulatory inspections
Excellent written and verbal communication with senior leadership and cross-functional partners
Willingness to work in a collaborative, fast-paced environment; US remote with travel to Boston
Prior experience leading a DM function and partnering with CRO/vendors

Responsibilities

Provide expertise to strategy and development of Clinical Data Management Systems for data quality
Directly manage and mentor DM staff and CRO data management teams with accountability for quality and timelines
Lead establishment of systems and processes to ensure clinical data security and integrity; own end-to-end DM deliverables
Develop and oversee the Data Management Plan, database design, edit checks, and CRF guidelines aligned with CDASH/SDTM/ADaM
Stay current on technologies and apply AI/automation to improve data quality and speed to database lock
Drive standardization and process improvements with defined actions and milestones
Serve as DM liaison for Head of Biometrics and cross-functional leadership; engage CRO/vendor partners and regulators
Lead CRO/vendor selection, contracting input, oversight, and budget management for DM activities
Ensure inspection readiness and representation during regulatory inspections and audits
Identify risks in data quality, timelines, and vendor performance with actionable mitigations
Represent DM in cross-functional project and submission teams; communicate status to senior leadership